(184 days)
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
8-CH Electroencephalography Amplifier capture brain wave signals through non-invasive electrodes, amplify the analog signals and convert to digital signals for computer use. The EEG monitoring panel can immediately display patient's brain wave to assure signal quality of testing requirements. Begin to test when signal quality lamp on EEG monitoring panel shows green light.
The provided text is a 510(k) Summary for a medical device (8-CH Electroencephalography Amplifier). This document focuses on demonstrating substantial equivalence to an existing predicate device rather than presenting a novel device that requires extensive clinical studies to prove performance against specific acceptance criteria.
Therefore, the information typically found in a study proving a device meets acceptance criteria (like specific sensitivity/specificity thresholds, sample sizes for test sets, expert adjudication methods, MRMC studies, or standalone algorithm performance) is not present in this type of regulatory submission. The goal here is to show that the new device is as safe and effective as a device already on the market, primarily through non-clinical testing and comparison of technical specifications.
Based on the provided text, here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance:
The document states: "All the test results demonstrate 8-CH Electroencephalography Amplifier meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." However, the specific acceptance criteria (e.g., threshold values for electrical safety, EMC) and the numerical results for each performance test (Software Validation, Electromagnetic compatibility and electrical safety, Performance, Usability) are not detailed in this summary. The table provided (Item Feature comparison) focuses on comparing the subject device's characteristics to the predicate device, not on specific performance metrics against acceptance criteria from a study.
2. Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not applicable/not provided. The studies mentioned (Software Validation, EMC, Performance, Usability) are non-clinical, likely involving testing of the device hardware and software, not on a dataset of patient EEG signals.
- Data Provenance: Not applicable. No clinical data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical test data or data requiring expert-established ground truth was used.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
Not applicable, as no clinical test data or data requiring adjudication was used.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
No MRMC study was done, and the device is an EEG amplifier, not an AI-driven diagnostic tool intended to assist human readers. The document explicitly states: "No clinical test data was used to support the decision of substantial equivalence."
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Not applicable. This is a hardware device (amplifier), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Not applicable, as no clinical data or ground truth adjudication was involved. The "ground truth" for this device's performance is compliance with engineering standards and specifications, as demonstrated through non-clinical testing.
8. The sample size for the training set:
Not applicable, as this is a hardware device undergoing non-clinical testing, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
Not applicable, as no training set was used.
Summary of Device Performance and Acceptance Criteria (based on available information):
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Overall Performance | "All the test results demonstrate 8-CH Electroencephalography Amplifier meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device." |
| Software Validation | Tests conducted and met requirements (specifics not detailed). |
| Electromagnetic Compatibility (EMC) & Electrical Safety | Tests conducted and met requirements. Specifically, "The subject device had meet the requirement of IEC 60601-2-26" for Amplifier CMRR (referential) and applied safety standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-26. |
| Performance (Functional) | Tests conducted and met requirements (specific functional performance metrics not detailed, but general capabilities like amplifying EEG signals, converting to digital, and displaying waveforms in real-time are stated in the Indications for Use and Device Description). Parameters compared to predicate device: - Resolution: 24 bit (Same as predicate) - Data Storage: Yes (Same as predicate) - Filter: Low pass filtering in amplifier (Same as predicate) - Sampling rate: 500Hz (Same as predicate EE-430 model) - Amplifier active shielding technique: Yes (Same as predicate) - Amplifier CMRR (referential): 94 dB at dc to 60 Hz (Similar to predicate's >100 dB, but met IEC 60601-2-26) - Amplifier Input Channels: 8 (Same as predicate EE-430 model) - Amplifier input impedance (referential): >10^9 Ω (Same as predicate) - Amplifier referential DC input channels: 8 (Same as predicate EE-430 model) - Amplifier USB interface: Yes (Same as predicate) |
| Usability | Tests conducted and met requirements (specifics not detailed). |
| Clinical Testing | No clinical test data was used to support substantial equivalence. |
Study Proving Device Meets Acceptance Criteria:
The "study" is a series of non-clinical safety and performance tests. The details of these tests and their specific acceptance criteria are not provided in this 510(k) summary, but the document asserts that the device met these pre-defined criteria.
- Sample Size: Not applicable. These were likely bench tests, not data-driven studies with "samples" in the traditional sense.
- Data Provenance: Not applicable, as no clinical data was used. The device itself was tested.
- Experts/Ground Truth/Adjudication/MRMC/Standalone: Not applicable, as this is a hardware amplifier submission based on non-clinical testing and comparison to a predicate device.
{0}------------------------------------------------
December 27, 2020
Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
HippoScreen Neurotech Corp. William Lan R&D Manager 2F., No. 578, Ruiguang Rd., Neihu District Taipei City, 11492 Taiwan
Re: K201747
Trade/Device Name: 8-CH Electroencephalography Amplifier Regulation Number: 21 CFR 882.1835 Regulation Name: Physiological Signal Amplifier Regulatory Class: Class II Product Code: GWL, OMC Dated: November 25, 2020 Received: November 27, 2020
Dear William Lan:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
{1}------------------------------------------------
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical. Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Indications for Use
510(k) Number (if known) K201747
Device Name
8-CH Electroencephalography Amplifier
Indications for Use (Describe)
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, s office, etc). The device is not intended for use in life support systems.
| Type of Use (Select one or both, as applicable) | ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ------------------------------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the
time to review instructions, search existing data sources, gather and maintain the data needed and complete
and review the collection of information. Send comments regarding this burden estimate or any other aspect
of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
"An agency may not conduct or sponsor and a person is not required to respond to a collection of
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
Traditional 510(k) 510 (k) Summary
510(k) Summary
{4}------------------------------------------------
Traditional 510(k) 510 (k) Summary
510(k) SUMMARY
| 1 | Type of Submission: | Traditional |
|---|---|---|
| 2 | Date of Summary: | 06/15/2020 |
| 3 | Submitter: | HippoScreen Neurotech Corp. |
| Address: | 2F., No. 578, Ruiguang Rd., Neihu District, TaipeiCity 11492, Taiwan, R.O.C | |
| Phone: | +886-2-87978060 | |
| Fax: | +886-2-87978090 | |
| Contact: | William Lan(william_lan@Hipposcreen-nc.com) |
4 Identification of the Device:
| Proprietary/Trade name: | 8-CH ElectroencephalographyAmplifier |
|---|---|
| Classification Product Code: | |
| Primary Product Code: | GWL |
| Additional Product Code: | OMC |
| Regulation Number: | 882.1835 |
| Regulation Description: | Physiological signal amplifier |
| Review Panel: | Neurology |
| Device Class: | II |
5 Identification of the Predicate Device:
| Predicate Device Name: | eego™ amplifiers |
|---|---|
| Manufacturer: | Eemagine Medical Imaging SolutionsGmbH |
| Classification Product Code: | |
| Primary Product Code: | GWL |
| Additional Product Code: | GWQ, OMC |
| Regulation number: | 882.1835 |
{5}------------------------------------------------
Traditional 510(k) 510 (k) Summary
| Device Class: | II |
|---|---|
| 510(k) Number: | K172312 |
6 Intended Use
Used to electrically amplify signals derived from electroencephalogram.
7 Indications for Use of the Device
The 8-CH Electroencephalography Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG signals, to transmit them digitally to a computer, and display waveform in real-time. The device is intended for use on humans. The device is intended for use in a clinical environment (e.g., hospital, physician's office, etc). The device is not intended for use in life support systems.
8 Device Description
8-CH Electroencephalography Amplifier capture brain wave signals through non-invasive electrodes, amplify the analog signals and convert to digital signals for computer use. The EEG monitoring panel can immediately display patient's brain wave to assure signal quality of testing requirements. Begin to test when signal quality lamp on EEG monitoring panel shows green light.
9 Non-clinical Testing
A series of safety and performance tests were conducted on the subject device, 8-CH Electroencephalography Amplifier.
- . Software Validation
- Electromagnetic compatibility and electrical safety
- Performance
- Usability
{6}------------------------------------------------
All the test results demonstrate 8-CH Electroencephalography Amplifier meets the requirements of its pre-defined acceptance criteria and intended use, and is substantially equivalent to the predicate device.
10 Clinical and Usability Testing
No clinical test data was used to support the decision of substantial equivalence.
11 Substantial Equivalence Determination
The 8-CH Electroencephalography Amplifier submitted in this 510(k) file is substantially equivalent in intended use, has similar technology/principles of operation, and similar performance to the cleared eego™ amplifiers (K172312). Differences between the devices cited in this section do not raise any new issue of substantial equivalence.
| ItemFeature | Subject device | Predicate device | Substantialequivalencedetermination |
|---|---|---|---|
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging SolutionsGmbH | |
| Proprietary Name | 8-CH ElectroencephalographyAmplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| Model Name | EAmp-0001 | EE-2XX series (EE-211, EE-212,EE-213, EE-221, EE-222, EE-224)andEE-4XX series (EE-411, EE-430) | N/A |
| Intended Use | Used to electrically amplify signalsderived from electroencephalogram. | Used to electrically amplify signalsderived from electroencephalogram. | Same.Both devices areamplifiers ofEEG signals. |
| ItemFeature | Subject device | Predicate device | Substantialequivalencedetermination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging Solutions GmbH | |
| Proprietary Name | 8-CH ElectroencephalographyAmplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| Indication for Use | The 8-CH ElectroencephalographyAmplifier is intended to be used by orunder the direction of a physician foracquisition of EEG signals, totransmit them digitally to a computer,and display waveform in real-time.The device is intended for use onhumans. The device is intended foruse in a clinical environment (e.g.,hospital, physician's office, etc). Thedevice is not intended for use in lifesupport systems. | The eego amplifier is intended to beused by or under the direction of aphysician for acquisition of EEGsignals and to transmit them digitallyto a computer. The device is intendedfor use on humans. The device isintended for use in a clinicalenvironment (e.g., hospital,physician's office, etc). The device isnot intended for use in life supportsystems. | Same.Both devices areintended foracquisition ofEEG signals to acomputer. |
| Type of use | Prescription Use | Prescription Use | Same |
| Modes ofOperation | Electroencephalography (EEG) | Electroencephalography (EEG) | Same |
| Environment ofUse | Clinical environment(Example: hospital, physician'soffice, etc) | Clinical environment(Example: hospital, physician'soffice, etc) | Same |
| Size | 220 x 50 x 153 mm | 205 x 22 x 160 mm | Different butdoes not impactsafety andeffectiveness ofsubject device |
| Weight | 600g | < 500g | Different but |
| ItemFeature | Subject device | Predicate device | Substantialequivalencedetermination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging SolutionsGmbH | |
| Proprietary Name | 8-CH ElectroencephalographyAmplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | does not impactsafety andeffectiveness ofsubject device |
| Resolution | 24 bit | 24 bit | Same |
| Data Storage | Yes | Yes | Same |
| Electrodeimpedancemeasurement | No | Yes | Different butdoes not impactsafety andeffectiveness ofsubject device |
| Filter | Low pass filtering in amplifier | Low pass filtering in amplifier | Same |
| Patient Contact | NoPatient contact is made bycommercially available electrodesand transducers | NoPatient contact is made by theWaveguardTM EEG Cap (K110223). | Same.Both contacts aremade by EEGcap. |
| Sampling rate | 500Hz | EE-2XX Series:Up to 16384 Hz Set through the userinterface of the SoftwareDevelopmentKit (SDK) software | Same as eegoEE-430(EE-430 is500Hz) |
| Video | No | EE-4XX Series: 500 to 2048 HzOptional | Different but |
| Item | Subject device | Predicate device | Substantialequivalencedetermination |
| Feature | |||
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging SolutionsGmbH | |
| Proprietary Name | 8-CH ElectroencephalographyAmplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| does not impactsafety andeffectiveness ofsubject device | |||
| Amplifier activeshieldingtechnique | Yes(Protects the referential EEG inputsfrom environmental noise) | Yes(Protects the referential EEG inputsfrom environmental noise) | Same |
| Amplifier CMRR(referential) | 94 db at dc to 60 Hz | >100 dB | Similar(Subject devicehad meet therequirement ofIEC 60601-2-26) |
| Amplifier InputChannels | 8 | Up to 64 | Same as eegoEE-430 |
| Amplifier inputimpedance(referential) | >109 Ω | >109 Ω | Same |
| Amplifier power | AC input 100V~240V, 50-60HzDC output 5V/ 2.0A | EE-2XX Series: Rechargeableintegrated batteryEE-4XX Series: USB from Computer | Different butdoes not impactsafety andeffectiveness ofsubject device |
| Amplifieroperating time on | Not applicable | EE-2XX Series: Up to 4 hours | Different butdoes not impact |
| ItemFeature | Subject device | Predicate device | Substantialequivalencedetermination |
| Submitter | HippoScreen Neurotech Corp. | Eemagine Medical Imaging SolutionsGmbH | |
| Proprietary Name | 8-CH ElectroencephalographyAmplifier | eegoTM amplifiers | |
| 510(k) No. | K201747 | K172312 | |
| battery power | safety andeffectiveness ofsubject device | ||
| AmplifierreferentialDC input channels | 8 | Yes8, 16, 32, or 64 channels | Same as eegoEE-430 |
| Amplifier triggerinput | No | Yes,EE-2XX Series: Optional 8 bit TTLEE-4XX Series: Optional 2 bit TTL | Different butdoes not impactsafety andeffectiveness ofsubject device |
| Amplifier triggerinput channel | No | Yes(Parallel) | Different butdoes not impactsafety andeffectiveness ofsubject device |
| Amplifier USBinterface | Yes | Yes | Same |
| Safety standardsapplied | IEC 60601-1IEC 60601-1-2IEC 60601-2-26 | IEC 60601-1IEC 60601-1-2IEC 60601-2-26IEC 62133 | Similar(Appropriatestandards areapplied on thesubject device.) |
{7}------------------------------------------------
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
{11}------------------------------------------------
12 Similarity and Difference
The 8-CH Electroencephalography Amplifier has been compared with eego™ amplifiers. The subject device and predicate device has same intended use, indication for use, type of use, modes of operation, environment of use, resolution, data storage function, filter, patient contact, sampling rate, amplifier active shielding technique, amplifier input channels, amplifier input impedance (referential), amplifier referential DC input channels, and amplifier USB interface.
Although there are some functions that are different between two devices, such as electrode impedance measurement, video function, amplifier power, amplifier trigger input function, and amplifier input channel, the function of subject device did not exceed that of the predicate device. Also, performance tests have been completed to demonstrate that the differences between these parameters would not impact the safety and effectiveness of the subject device.
As for amplifier CMRR (referential), subject device is a little bit lower than that of the predicated device. However, subject device had met the requirement of IEC 60601-2-26.
In conclusion, the subject device has undergone safety and performance tests, and the results complied with the test requests; therefore, the difference between the subject device and the predicate device did not raise any problem of substantial equivalence. The subject device is substantially equivalent to the predicate device in intended use, safety and performance claims.
13 Conclusion
In conclusion, HippoScreen Neurotech Corp. believes that 8-CH Electroencephalography Amplifier maintains the same safety and effectiveness, and thus, is substantially equivalent to the predicate device.
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).